Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial.

introductionPremature ovarian insufficiency (POI) is a complicated reproductive endocrine disease seriously affecting physiological function and fertility in women. Its clinical features include amenorrhoea or infrequent menstruation, oestrogen deficiency and elevated levels of gonadotropins. At present, conventional treatments for POI in clinical practice are unable to fundamentally improve ovarian function or solve fertility problems, and often have certain side effects. Adipose tissue-derived stromal vascular fraction (SVF) contains various cell types, including adipose-derived stem/stromal cells, stromal cells, endothelial cells, fibroblasts and macrophages. Recently, SVF has shown tremendous potential in treating many refractory diseases, offering a promising therapeutic option for improving ovarian function. Although SVF has shown therapeutic effects in animal models of POI, there is insufficient evidence demonstrating the efficacy and safety of autologous SVF in women with POI. METHODS AND ANALYSIS: This study is a single-centre randomised controlled trial designed to explore the efficacy and safety of using autologous SVF in improving pregnancy outcomes in patients with infertility diagnosed with POI. A total of 308 women meeting the eligibility criteria will be randomly assigned in a 1:1 ratio to either the SVF group or the control group. The control group will receive conventional assisted reproductive technology treatment, including in vitro fertilisation, embryo transfer and intracytoplasmic sperm injection. In the SVF group, patients will undergo bilateral intraovarian injections of the SVF suspension under ultrasound guidance. Their in vitro fertilisation cycles will commence 4-8 weeks after SVF injection. The primary outcome of this trial is the cumulative clinical pregnancy rate within 6 months. Aside from this, secondary outcomes including menstrual volume and duration, ovarian volume, antral follicle count, and serum levels of anti-mullerian hormone and sex hormone (oestrogen and follicle-stimulating hormone) will be measured. All adverse events will be monitored and recorded within a 6-month follow-up period. Additionally, pregnancy outcomes and the health status of the offspring will be tracked through telephone follow-up for 2 years. ETHICS AND DISSEMINATION: This trial has been reviewed and approved by the Ethics Committee of Peking University Third Hospital (approval number: IRB00006761-M2024330). We will ensure that each patient has signed informed consent before participation in the trial. The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06481969.